MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PROGRASP FORCEPS

Model Number 471093-11

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the prograsp forceps instrument involved with this complaint and completed the device evaluation.Failure analysis was able to confirm/reproduce the reported complaint.The instrument was found to have the grip pin dislodged at the distal end.The grips could not open or close properly.The pin remained installed on one of the grips and no pieces were missing.The pin was re-aligned with the other grip and the pin was re-installed.The grips were able to open and close properly and the pin showed no signs of physical damage.The root cause is attributed to manufacturing.A review of the instrument log of the prograsp forceps (part # 471093-11 / lot # k11210809-0051) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021 on system (b)(4).The instrument has maximum 18 allotted uses.The alleged event occurred on the 9th use of the instrument.A review of the site's complaint history does not show any additional complaints for this product.No image or procedure video was provided for review.This event is being reported due to the following conclusion: failure analysis confirmed the instrument's grip was dislodged with no evidence of user mishandling/misuse.This instrument is designed with a grip pin on the distal end allowing articulation of the instrument assemblies they are holding together and is secured to the device by swaging.If the pin is not properly fused together, the pin could become dislodged and fall into the patient.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.

Event Description

It was reported that during central processing, the prograsp forceps instrument had a loose pin.There was no report of patient involvement.On 24-nov-2021, intuitive surgical, inc.(isi) contacted the robotic coordinator and obtained the following information: the damage did not occur during a procedure.The instrument did not have any damage when it arrived to central processing.The damage occurred during central processing.

• Brand Name: ENDOWRIST
• Type of Device: PROGRASP FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12965274
• MDR Text Key: 286749188
• Report Number: 2955842-2021-11699
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(10)K11210809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471093-11
• Device Catalogue Number: 471093
• Device Lot Number: K11210809 0051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES